MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 NEUTRAL ARCOMXL LNR 36MM H; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products - (b)(4).

Event Description

It was reported that during a patients hip arthroplasty revision the liner would not seat with the acetabular shell.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the liner found multiple forms of damage consistent with attempts to insert and remove the liner from a shell.The flat rim of the liner is gouged in several places.Sections of the barb and a few of the scallops have also been damaged/deformed.No markings were found that would indicate the screw used in the shell came into contact with the liner at the time of insertion.No dimensional analysis was performed as the nature of damage may impact the resulting measurements.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Another liner was assembled with the shell upon receipt.When disassembled, there was soft tissue on the inside of the cup.Surgical technique states, "ensure the interior of the shell is dry and free of debris and overhanging soft tissue is removed".Although this liner was not assembled to the shell, both of the other products received from this surgeon from this procedure had significant soft tissue in the cup.The tissue and fluid within the cup upon impaction likely caused or contributed to the liner not being able to be seated.As a liner was able to be seated in this cup, we cannot completely attribute the root cause to this.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 NEUTRAL ARCOMXL LNR 36MM H
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6746392
• MDR Text Key: 81122680
• Report Number: 0001825034-2017-05249
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/23/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000743
• Device Lot Number: 3901391
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 110010250, G7 SHELL, R3612637A
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR